Kornimate/medical-research-clean huggingface dataset:
curcumin associated with thiopurin in the prevention of post-op recurrence in crohn disease

Conditions: Crohn's Disease

Summary: curcumin, the active ingredient of turmeric, has been used for long term in the treatment of inflammatory conditions. inhibition of nf-κb is postulated as the main mechanism responsible for the anti-inflammatory effect of curcumin aim : to study the effect of curcumin, 3g per day, as compared to placebo, combined with thiopurines in the prevention of crohn's disease post-operative recurrence.

122 subjects, operated on for crohn disease, will be included in the study. after ileo-colonic resection, subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. rutggerts endoscopic score at 6 months will be the main judgment criteria.

Eligibility criteria:
inclusion criteria: * crohn's disease confirmed by radiographic, endoscopic or histologic criteria * age \> 18 yr * affiliated to french health insurance * operated on less than 15 days ago for ileal, colonic or ileo-colonic crohn's disease with all macroscopic lesions being removed, with an anastomosis which can be reached by ileocolonoscopy exclusion criteria: * ulcerative colitis * pregnant or nursing woman * refusal of contraceptive measure for childbearing potential, woman or fertile man * indication of anti-tnfα treatment * concomitant treatment including antibiotics, probiotics, mesalazine, methotrexate, cyclosporine, tacrolimus, anti-tnfα, ustekinumab, vedolizumab * concomitant treatment with corticosteroids, except in case of tapering a treatment initiated before surgery * renal insufficiency ( serum creatinine 2n) * chronic hepatic disease except for primary sclerosing cholangitis * alat , asat, alkaline phosphatases, or bilirubin \> 3n * current infection to hiv, hbv (except if hbv ac positives), hcv * contraindication to thiopurines * unwillingness of the patient

Keywords: curcumin. crohn's disease. post-operative recurrence. thiopurines . rutgeerts endoscopic score
correlation of imaging findings with clinical findings and patient outcomes in prostate cancer

Conditions: Prostate Cancer

Summary: mri is being increasingly relied upon for detection, staging and management of prostate cancer. in this study patients with risk of prostate cancer will be recommended to have a pelvic mri prior to the standard biopsy of the prostate and standard treatment of any detected prostate cancer. the results of the mri will be compared to standard diagnosis techniques to see if cancer can be more accurately detected.

the study team hypothesizes that strategic use of advanced mri methods will provide a more accurate and less invasive approach for diagnosis and management of prostate cancer. the primary objectives are: 1. to develop advanced mri methods and optimal mri protocols for detection, staging, and follow-up of prostate cancer. 2. to evaluate the diagnostic performance of mri-guided biopsy methods and correlate mri findings with the pathological grade of cancer. 3. to correlate prostate mri findings and biopsy results with patient progress and outcomes. 4. to evaluate the diagnostic accuracy of mri in disease re-classification in patients on active surveillance. secondary objectives: 1. to apply computer-aided advanced image analytic techniques (computer-assisted diagnostics- cad) to extract mri features of patient clinical scans that correlate with diagnosis and grade of prostate cancer. 2. to study mri features of lesions that mimic prostate cancer on imaging eg - chronic prostatitis, post treatment changes. 3. to evaluate the impact of mri in decision making and choice of treatment by physicians and patients.

Eligibility criteria:
inclusion criteria: * patients with a suspicion (elevated psa and/or abnormal digital rectal exam)/ diagnosis of prostate cancer inclusion criteria for sub-group follow-up scans: 1a. patients who have undergone standard trus biopsy or trus with targeted biopsy (i.e cognitive trus, mr-trus fusion or trus + in-gantry biopsy) exclusion criteria: * patients with ferromagnetic or otherwise non-mri compatible aneurysm clips. * the presence of an implanted pacemaker or implanted defibrillator device. * patients with contraindications for mri due to embedded foreign metallic objects. bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient. * implanted medical device not described above that is not mri-compatible; * known history of severe claustrophobia; * for patients with known history of allergic reaction to magnetic resonance (mr) contrast material or abnormal kidney function (glomerular filtration rate (gfr) \< 30 ml/min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed; * minors will be excluded. * prisoners and members of other vulnerable populations will be excluded from this study as these populations will not provide any additional unique information to or uniquely benefit from the study.

Keywords: trus biopsy pelvic mri
prediction of hepatocellular carcinoma recurrence after curative treatment by monitoring circulating tumor dna

Conditions: Hepatocellular Carcinoma

Summary: the goal of the remnant study is to confirm the clinical value of detecting a new biomarker, ctdna (circulating tumor dna), in the follow-up of patients with operated liver cancer. in order to meet this objective, this biomarker will be measured in your blood before and after surgery, at three and six months.

hepatocellular carcinoma (hcc) is the most common primary liver cancer and develops in 80% of cases in the context of underlying cirrhosis1. surgical resection, percutaneous destruction and liver transplantation are the three treatments considered curative with a non-negligible risk of recurrence of 35-50% at 2 years2. several data in the literature suggest that small subclinical tumors can be detected by circulating tumor dna (ctdna), and that the amount of tcdna detected seems to correlate with risk factors for recurrence such as tumor size or microvascular invasion3, 4. the objective of this pilot study is to evaluate the detection of ctdna following tumor ablation and its impact on early recurrence.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. hcc diagnosed on consensus radiological criteria in cirrhotic patients (easl-eortc 2012): helical ct or mri with triple arterial, portal and late acquisition. the diagnosis is based on the presence of hypervascularization at the early arterial time (wash-in) with wash-out (hypodensity or hypointensity compared to non-tumor liver parenchyma) at the portal phase or late phase compared to non-tumor parenchyma. 3. hcc diagnosed histologically in the absence of a diagnosis on imaging (see ic n°2 above) 4. patient operated on for liver resection or radiofrequency destruction 5. treatment decision validated by the digestive oncology pcr 6. patient having read and understood the information letter and signed the non-opposition form 7. patient follow-up at the charles nicolle university hospital in rouen exclusion criteria: 1. other active cancer or hematological malignancy 2. contra-indication to surgery 3. patient not affiliated to the social security system 4. pregnant woman or parturient or breastfeeding 5. person under court protection, sub guardianship or curatorship

Keywords: ctdna biomarker
study of mr-based igrt for prostate cancer

Conditions: Prostate Cancer

Summary: mr (magnetic resonance imaging) - based igrt (image-guided radiotherapy) for patients with prostate carcinoma.

single arm, phase ii study, mr (magnetic resonance imaging) - based igrt (image-guided radiotherapy) of prostate cancer. primary endpoint: grade 2+ gi (gastrointestinal) and genitourinary (gu) toxicity after 2 years.

Eligibility criteria:
inclusion criteria: * histologically proven prostate cancer * indication for curative treatment * ecog performance scale 0-2 * informed consent exclusion criteria: * contraindications for curative treatment * age\<18year * previous pelvic radiotherapy or prostatic treatment like turp (transurethral resection of prostate), hifu (high intensity focused ultrasound) * serious comorbidity leading to inability for igrt (image-guided radiotherapy) * contraindications for mri (magnetic resonance imaging)
extracorporeal shock wave therapy treatment for nocturnal leg cramps

Conditions: Nocturnal Leg Cramps

Summary: nocturnal leg cramps (nlcs) are often described as a symptom of sudden and involuntary muscle contraction at night, which often affects sleep quality due to pain and tight discomfort in the thigh, calf and foot. the investigator performed extracorporeal shock wave therapy (eswt). this experiment used a randomized experiment to assess the immediate, short-term and long-term effects of extracorporeal shock wave therapy on patients with nocturnal leg cramps.

nocturnal leg cramps (nlcs) are often described as a symptom of sudden and involuntary muscle contraction at night, which often affects sleep quality due to pain and tight discomfort in the thigh, calf and foot. the pathophysiology of nocturnal leg cramps is unclear, but it is generally considered to be associated with excitability lower motor neurons, sleep posture at night, leg muscle fatigue, nerve disability or damage (eg, parkinson's disease), metabolic diseases (eg : hyperphosphatemia). generally, quinine or magnesium oxide is the most commonly used pharmacological treatment. the common non-drug treatments are stretching exercise, massage or hot therapy, but there is not enough evidence to indicate which treatment is specific effective. in a previous study, they proposed that nocturnal leg cramps may be associated with myofascial trigger points (mtrps) of the gastrocnemius. other studies have also proposed that extracorporeal shock wave therapy (eswt) applying to the mtrps of the upper trapezius muscle could improve cervicogenic headache. we will conduct a randomized parallel study to investigate the efficacy of eswt on nocturnal leg cramps. participants will be randomized into two groups: one is only general physical therapy (gpt) and the other one is eswt + gpt. the outcome measurement tools including the frequency of nocturnal leg cramps, visual analog scale (vas), pain pressure threshold (ppt) and muscle tone in the gastrocnemius, range of motion of knee and ankle, and quality of sleep questionnaire were used to compare two groups with regard to the pain intensity, quality of sleep, and overall satisfaction in subjects with nocturnal leg cramps.

Eligibility criteria:
inclusion criteria: 1. ≥ 20 y/o patients with nlcs: (1) 4 times/week, last 2 weeks; (2) occurred in nighttime or resting time of daytime 2. patients with mtrps on gastrocnemius (according to the diagnostic criteria proposed by simons \& travell) exclusion criteria: 1. (1) taking medication for leg cramps (eg. quinine, magnesium oxide); (2) other drugs that affect research and evaluation (eg. diuretics, statins, calcium channel blockers, anticonvulsants) 2. congenital lower limb musculoskeletal diseases, lower limb or spine surgery 3. uncommunicated or cognitive impaired 4. patients refused to be recruited

Keywords: myofascial trigger points nocturnal leg cramps extracorporeal shock wave therapy
detection of krupple like factor -1(klf1/ eklf) dna mutations in beta thalassemia patients

Conditions: EKLF Mutations in Beta Thalassemia Patients

Summary: * detection of klf1 gene mutations in patients with beta thalassemia considering the alpha and beta molecular status of these patients. * study the relation between genotypic mutational status of klf1 mutation with the level of hb f and hb a2 in the patients of beta thalassemia.

thalassemias are inherited abnormalities in globin chain synthesis of hemoglobin and one of the most common single gene disorders in the world. β-thalassemia is caused by reduced (β+) or absent (β0) synthesis of the β-globin chains of haemoglobin. three clinical and hematological conditions of increasing severity are recognized: the β-thalassemia trait, thalassemia intermedia and thalassemia major. the erythroid kruppel-like factor (eklf or klf1) is a master regulator of terminal erythroid differentiation, controlling expression of many key pathways and structures including cell division, the cell membrane and cytoskeleton, heme and globin synthesis. the klf1 works as a key regulator of γ-globin to β-globin switch by up-regulation of pum1 that binds to fetal γ globin mrna impairing its stability and translation and by bcl11a expression that represses γ-globin expression. previous studies reported that klf1 mutations have been identified in a variety of erythroid conditions like hereditary persistence of fetal hemoglobin, congenital dyserythropoietic anemia and borderline hba2. an indian study on klf1 gene variations found a marginal significance in the thalassemia intermedia group (14%) as against the thalassemia major group (2.0%). also, a case report on a chinese family with twin brothers, both of whom had the same genotype of β0/β0, reported that klf1 mutations have a role in modulating the phenotypic severity of β-thalassemia. in our study, where there is high incidence of beta thalassemia in egypt, we try to detect klf1 mutations and its relation to clinical phenotype of these patients.

Eligibility criteria:
inclusion criteria: * patients with β-thalassemia (intermedia and major) of both genders at any age exclusion criteria: * patients with any other type of haemolytic anaemias. * patients on hydroxyurea therapy
mediastinal lymph node dissection versus spared mediastinal lymph node dissection in stage i ggn nsclc

Conditions: Lung Neoplasms; Lymph Node Excision

Summary: lung cancer is the leading cause of cancer related death worldwide. lobectomy or sub-lobectomy with mediastinal lymph node dissection is the standard surgery. about 50% lung nodules are pure ground-glass or part-solid nodules. non-solid nodules rarely develop mediastinal lymph node metastasis. the present study is a prospective, multicenter and randomized clinical trial, comparing the overall survival and disease-free survival of whether performing mediastinal lymph node dissection in non-small cell lung cancer with ground-glass nodule ct features.

the study is a non-inferior statistical comparison, with 681 patients in each group. the anticipated enroll period is 3 years, followed by observation period of 5 years.

Eligibility criteria:
inclusion criteria: * thin-slice hrct shows single ggn with c/t ≤ 0.5 and no lymph node metastasis; * clinical stage ia nsclc (tnm 8th classification) diagnosed prior or in surgery; * no history of malignancies within past 5 years or lung surgery; * no anti-cancer treatment prior to surgery. exclusion criteria: * simultaneous or metachronous (within the past 5 years) double cancers; * active bacterial or fungous infection; * interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema; * systemic steroidal medication; * uncontrollable diabetes mellitus; (vi) uncontrollable hypertension or history of severe heart disease, heart failure.

Keywords: non-small cell lung cancer mediastinal lymph node dissection ground-glass nodules
a study of infusion site pain after infusion of excipients in participants with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: the main purpose of this study is to evaluate the effect of excipients sodium citrate and treprostinil without insulin on local infusion site pain in participants with type 1 diabetes mellitus (t1dm) on continuous subcutaneous insulin infusion (csii). the study may last up to 36 days including a screening period and 3 visits.


Eligibility criteria:
inclusion criteria: * t1d for at least 1 year and continuously using insulin for at least 1 year * using an insulin pump for at least the last 6 months * have hemoglobin a1c (hba1c) value of ≤ 9.0% * have a body mass index (bmi) within the range of 18.5 to 35.0 kilograms per square meter (kg/m²) * have medical and laboratory test results that are acceptable for the study * have venous access sufficient to allow for blood sampling exclusion criteria: * hemophilia or any other bleeding disorder * have a pathologic tuning fork test as assessed with a rydel-seiffer tuning fork * are taking anesthetics or pain medication regularly or intermittently which could interfere with interpretation of pain scale * have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the last 90 days prior to screening * have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within the last 6 months prior to screening * have any hypersensitivity or allergy to any of the diluents or excipients used in this trial * have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study * have participated, within the last 30 days, in a clinical trial involving an investigational product * have used or are currently using lyumjev® as part of their standard insulin therapy

Keywords: humalog - insulin lispro citrate infusion site pain excipients
neoadjuvant short-course hypofractionated pbt for non-metastatic rps

Conditions: Retroperitoneal Sarcoma

Summary: the investigators' study titled "protons-rps: a phase ii non-randomized open-label single-arm trial of neoadjuvant short-course hypofractionated proton beam therapy for non-metastatic retroperitoneal sarcoma" is a phase ii trial evaluating the safety and efficacy of hypofractionated proton beam therapy (h-pbt) in the neoadjuvant (na) setting for patients with non-metastatic retroperitoneal sarcoma (rps) planned for surgical resection. this trial will include adult patients with resectable rps.

the investigators' primary outcome is overall complication rate after treatment with na h-pbt and surgical resection based on national cancer institute (nci) common terminology criteria for adverse events (ctcae) version 5.0.2 secondary objectives include evaluating the acute toxicity of h-pbt prior to surgical resection, rate of progression between diagnosis and definitive resection, early post-operative complication rate after resection of rps in patients who received na h-pbt, and local recurrence-free survival at 1 and 2 years. a priori subset analyses will be conducted for patients with well-differentiated and dedifferentiated liposarcoma. the investigators plan to accrue a minimum of 44 patients to evaluate the investigators' primary outcome. treatment will be 5 doses of h-pbt including a simultaneous integrated boost to at-risk margins followed by surgical resection after 4-6 weeks. patients will be followed in the post-operative setting according to standard of care surveillance for rps.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years of age) * patients with primary non-recurrent retroperitoneal sarcoma * calculated creatinine clearance ≥50 ml/min and functional contralateral kidney based on nuclear medicine renal scan * normal bone marrow function (wbc ≥ 4 x109 /l) * eastern cooperative oncology group status ≤ 2 * cardiac function ≤ new york heart association class ii * proton beam therapy approved by insurance (including medicare/medicaid) exclusion criteria: * evidence of metastatic disease on staging ct of chest/abdomen/pelvis * history of abdominal or pelvic radiation therapy * inability to tolerate supine position for duration of pbt simulation or treatment * tumor originating from gastrointestinal or gynecologic organs * specific sarcoma histologies including osteosarcoma, desmoid tumors, chondrosarcoma arising from vertebrae or pelvic bones, embryonal rhabdomyosarcoma * tumor extending into femoral or obturator canal * history of systemic lupus erythematosus or ulcerative colitis * genetic syndrome with radiation-associated tumorigenicity (i.e.: li-fraumeni) * presence of clinically significant ascites * co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators.
different lugol's solution concentration for image quality of esophageal lesions in chromoendoscopy with iodine staining

Conditions: Image Quality of Early Esophageal Squamous Neoplasia; Endoscopists'Subjective Assessments

Summary: the purpose of this study is to assess whether lower lugol's solution concentration can perceive the same image quality of early esophageal squamous neoplasia.

chromoendoscopy using lugol's solution is effective for the detection of early esophageal squamous neoplasia. however, this modality may cause severe chest pain and discomfort owing to mucosal irritation. this study was to test whether a lower concentration of lugol's solution can provide satisfied image quality of early esophageal squamous neoplasia and has lower mucosal irritation.

Eligibility criteria:
inclusion criteria: patients with early esophageal squamous neoplasia who underwent endoscopic submucosal dissection. exclusion criteria: after esophageal surgery or endoscopic treatment ; known esophageal radiotherapy or chemotherapy ; esophageal stenosis; acute bleeding; a known allergy to iodine; coagulopathy (prothrombin time \ 50 seconds); having food retention; severe hepatic ,renal, cardiovascular or metabolic dysfunction ; being pregnant or lactating.
rtms on appetite and cognitive function in schizophrenia

Conditions: Schizophrenia

Summary: the weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. rtms is a promising novel intervention, which have strong potentials on moderating increased appetite and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression. therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of rtms, using itbs pattern, on prevention and treatment for elevated appetite and cognitive deficiency in individual with schizophrenia.

the weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. the cognitive function deficit has also been a major symptom for schizophrenia. however, metabolic dysfunction could further impair the cognition. rtms is a promising novel intervention, which have strong potentials on moderating increased appetite and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression. therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of rtms, using itbs pattern, on prevention of the elevated appetite and cognitive deficiency in individual with schizophrenia. the intervention will last for 5 continuous days and the follow-ups are scheduled at baseline, 6days and 36days. the primary outcomes include the change of mccb score, tfeq score and eeg data. secondary outcomes include the change of serum metabolic indexes and anthropometry indexes.

Eligibility criteria:
inclusion criteria: * patients with schizophrenia in accordance with dsm-5 * commorbid with significant weight gain after antipsychotics * informed consent exclusion criteria: * diagnosed with other mental disease in accordance with dsm-5 * comorbid with other severe physiological disease * used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before * drug or alcohol abuse * pregnant or lactating * contraindication to rtms

Keywords: schizophrenia rtms appetite cognitive function